1. Field of the Invention
The invention generally relates to assessing the level of risk a person has or may have for preterm delivery due to preterm premature rupture of membranes (PPROM). In particular, the invention provides a method to assess the level of risk for preterm delivery due to PPROM by detecting SERPINH1 gene variants that express low levels of the gene product, heat shock protein Hsp47. The method can be used to help advise patients that are pregnant or that are planning a pregnancy, as well as to advise prospective parents regarding chances that their child may be born prematurely as a result of PPROM.
2. Background of the Invention
Prematurity is a major problem in the United States, costing the health care system more than 26 billion dollars each year for the care of premature infants. Long-term disabilities associated with prematurity add additional costs. There are significant racial/ethnic disparities in the incidence of prematurity, with African-American women experiencing a disproportionate number of preterm births (2 to 3-fold more) compared to European-American women (1, 2). This disparity cannot be explained by socioeconomic status or access to health care (3). Several factors are thought to contribute to premature birth including infection, decidual bleeding/hemorrhage, stress, lifestyle (e.g., smoking, illicit drug use) and genetics. There is emerging evidence suggesting that interactions among these factors (i.e., gene-environment interactions) can increase the likelihood of a preterm birth (4, 5).
The prior art has thus far failed to provide a genetic method to identify women who are at risk for preterm delivery due to PPROM, particularly women of African-American descent, who are particularly prone to preterm delivery.